The present invention relates to a nocturnal penile tumescence and rigidity monitor. More particularly, the present invention relates to a nocturnal penile tumescence and rigidity monitor including detachable loops.
As previously indicated in Ser. No. 318,373, filed Nov. 5, 1981, and U.S. Pat. No. 4,474,187, studies have shown that men with psychogenic impotence generally have normal sleep erections, whereas men with organic impotence have sleep erections that correspond to their impaired wake performance. Such studies have alerted the scientific community of the potential usefulness of nocturnal penile tumescence monitoring in the differential diagnosis of sexual impotence. As a result of the recognition that nocturnal penile tumescence monitoring can be of assistance in diagnosing male erectile impotence, various types of devices and techniques for conducting such monitoring have been developed.
In an article entitled "A Simple and Inexpensive Transducer for Quantitative Measurement of Penile Erection During Sleep", Behavior Research Methods Methods and Instrumentation, Volume 1, pages 251-252, 1969, Ismet Karacan describes a mercury strain-gauge transducer for detecting penile erection. The transducer device is an elastomeric mercury filled tube which is suitably connected to a Wheatstone Bridge and amplifier circuit for recording purposes. As the transducer changes size during penile erection, its electrical resistance changes thereby causing the amplified output from the Wheatstone Bridge to change. The amplified changes in the output are recorded enabling penile activity to be recorded.
In an article entitled "Some Characteristics of Nocturnal Penile Tumescence in Young Adults", Archives General Psychiatry, Volume 26, pages 351-356, 1972, Ismet Karacan et al. describes the normative characteristics of nocturnal penile tumescence (NPT) in a group of 20 to 26 year old men who were measured during continuous all-night recording utilizing the mercury strain-gauge transducer.
Additionally, a number of devices and procedures for monitoring penile tumescence during sleep are noted and referenced in an article entitled "Sleep Related Penile Tumescence as a Function of Age", American Journal of Psychiatry, Volume 132, page 9, September 1975.
In U.S. Pat. No. 4,103,678 issued to Ismet Karacan et al. an apparatus is disclosed for recording minute variations in mercury strain-gauge transducers positioned at the base and the tip of the penis.
The above-referenced materials relate to nocturnal penile tumescence activity and not to the measurement of penile rigidity or hardness during the tumescent event. While it is recognized that nocturnal penile tumescence activity is important to the evaluation of organic impotence, another significant aspect in evaluating organic impotence is the quality of rigidity or hardness achieved during the penile tumescent event.
The mercury strain-gauges described by Ismet Karacan provide a measurement of the change in penile size during a penile tumescent event by changing their impedance as they expand and contract with variations in the penis circumference. The mercury strain-gauges do not, however, provide for measurement of penile rigidity or hardness since the strain-gauges are very elastomeric. A very slight amount of force will fully expand the strain-gauges just as would a larger amount of force.
In addition, the mercury strain-gauge necessitates a rather elaborate monitoring mechanism. The monitoring normally must occur in a health care facility under the supervision of trained professionals. This requires that the patient may be in the health care facility overnight and be subjected to fairly elaborate testing. In addition to creating a substantial imposition on the patient's daily routine, substantial expense is associated with the support facilities and support personnel required to obtain valid test results.
In an article entitled "Nocturnal Penile Tumescence Monitoring with Stamps", Urology, Volume 15, pages 171-172, 1980, a stamp technique is described for detecting complete nocturnal erection for the evaluation of impotence. In this technique, a strip of four postage type stamps is wrapped snuggly around the penis, and the overlapping stamp is moistened to provide a one half to one stamp overlapping seal. The nocturnal penile tumescent stamps, each one and one quarter by one inch, are made on ten by eight inch sheets of paper having water base glue on the opposite side. The patients or subjects are able to perform the evaluations at home rather than go to the hospital, resulting in substantial financial savings. The article indicated that three nights of inhospital nocturnal penile tumescence testing including direct observation of indicated erections and physicians professional fee, currently cost roughly $500. The stamp testing method costs $7.50 for three nights of outpatient testing.
The stamps have a tendency to release after being wetted and stuck together. In addition, the force required to break the perforations between adjacent stamps varies substantially. Thus, the above described stamp technique does not provide a method for detecting a predetermined penile rigidity or hardness.
In Ser. No. 318,373 and U.S. Pat. No. 4,474,187, there is disclosed threshold penile rigidity measuring devices which provide for accurate measurement of a predetermined penile rigidity during a penile tumescence event. However, while these devices provide a safe, simple, accurate and reproducible test which can be used at home to provide a very effective tool in the evaluation of impotence, they do not provide for measuring and recording of penile rigidity at various times throughout the tumescence events and accordingly do not provide any record or indication of the duration which the rigidity is maintained. These devices included a ring-like structure having an attachment mechanism for releasably attaching the ring-like structure to a penis. Associated with the ring-like structure is an apparatus for detecting a predetermined force in the penile tumescent event.
In U.S. Pat. No. 4,515,166 and Ser. No. 713,452, filed Mar. 19, 1985, there is disclosed a penile rigidity and tumescence monitor apparatus comprising transducer means for providing output signals indicative of penile rigidity and tumescence. Operatively associated with the transducer means is control means for providing control of the transducer means. The control means provides further for the acquisition of the output signals from the transducer means and storage of penile rigidity and tumescence data represented by the output signals. In one embodiment, the penile rigidity and tumescence monitor included a portable housing having an elongated, non-distensible, flexible member extending therefrom. The elongated member was constructed and arranged to form a loop-like portion at a first end, the loop-like portion being adapted for releasably encircling a penis about the circumference thereof. The elongated member was further slidably enclosed within a flexible, non-compressible conduit between the loop-like portion and the housing, the non-compressible conduit being suitably attached to the housing. Should the loop-like portion, and/or the elongated member be damaged, the nocturnal penile tumescence and rigidity monitor must be serviced at the factory. This results in lost time and is rather costly. Moreover, in typical usage, the loop-like portions are used many times over, being disinfected between uses. In view of the public's concern with cross contamination, this could negatively affect the usage of the tumescence and rigidity monitor. Moreover, the patient might potentially be exposed to transmission of disease from one patient to the next if the loop-like portions are not properly cleaned. Additionally, after a period of time, a loss of loop performance is detected.
The present invention overcomes these and many other problems associated with currently available devices.